SARS-CoV-2

Brief Description

GPHL and WPHL perform COVID-19 real-time RT-PCR assays that are approved for use only under the Food and Drug Administration’s Emergency Use Authorization, the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit EUA and the Aptima® SARS-CoV-2 Assay (Panther® System). This real-time RT-PCR assay is intended for the qualitative detection of SARS-CoV-2 RNA in clinical specimens collected from patients suspected of having COVID-19 (criteria includes clinical and/or epidemiological criteria).

Laboratory Unit

• Molecular Biology GPHL
• Virology WPHL

Methodology

• TMA
• DKA
• RT-PCR

Specimen Collection

• Nasopharyngeal (NP) swab: (Preferred)
  • Swab specimens should be collected using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Specimens should be collected, received, and tested at the lab within 72 hours of collection.
• Oropharyngeal (OP) swab:
  • Swab specimens should be collected using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Specimens should be collected, received, and tested at the lab within 72 hours of collection.
• Anterior Nasal Swab:
  • Swab specimens should be collected using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Specimens should be collected, received, and tested at the lab within 72 hours of collection.
• CDC reference: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinicalspecimens.html.

Storage/Transport

• Swab Specimen in VTM/UTM
  • Specimens should be refrigerated (2-8°C) and shipped using refrigerated (2-8°C) specimen outfit. If a delay in testing or shipping is expected, freeze specimens at (-70°C or colder) and ship using frozen (-20 °C or colder) specimen outfit.
• Swab Specimen in Molecular Transport Media 
  • Specimens should be at ambient (15-30 °C) for up to 7 days after collection.
• Swab Specimen in saline
  • Specimens stored in SalivaSecure can be shipped at (19-23 °C) but must not exceed shipping times above 56 hours. Can also be stored refrigerated (2-8 °C) for up to 24 hours.
• FRM-QA 4 Refrigeration Outfit Guide

Acceptable Specimen Type(s)

• Nasopharyngeal (NP) swab
• Oropharyngeal (OP) swab
• Anterior Nasal Swab

Test Request

• GPHL Apollo Web Portal
• Web Portal Instructions
• For manual orders, download the GPHL Submission Form

Possible Results

• Detected
• Not Detected
• Inconclusive
• Unsatisfactory

Reference Range

Not detected

Unacceptable Conditions

• Missing testing requisition
• Missing minimum of 2 patient identifiers
• Improper labeling
• Improper storage/transport of specimen
• No specimen received (empty collection tube)
• Wrong specimen type
• Specimens damaged, broken, or leaking upon arrival
• Patient identifier on specimen does not match that on physical or electronic submission form
• Received after 72 hours post collection if in VTM
• Received after 7 days if in Molecular Transport Media (MTM)
• Received after 48 hours if in saline
• Received after 24 hours if saliva
• Calcium alginate swabs
• Cotton swabs with wooden shafts

Interfering Substances

N/A

Result Reported

1-3 business days

Turnaround times may be affected by the scale of the event.

Fees

No charge

LOINC/Order Codes

94306-8 (Order code: 423000 Decatur, W423000 Waycross)